Job Summary

Title: Regulatory Affairs and Product Stewardship (RAPS), Pharmaceutical Solutions (PhS) Director

Pharma Solutions (PhS), an IFF Business, applies expert science to advance market-driven, healthy and sustainable solutions for pharmaceutical, dietary supplement and chemical industries.

In the Global Regulatory Affairs (GRA) team we have an opening for a Regulatory Affairs and Product Stewardship (RAPS) PhS director to lead the global regulatory team supporting the PhS business, and to drive regulatory activities for our ~$1B Pharmaceutical Solutions portfolio of businesses.

IFFs Pharmaceutical Solutions represent one of the industry’s broadest and most flexible portfolio of oral solid dosage advanced pharmaceutical ingredients and excipients. Our solutions for tablets, capsules, multiparticulates and suspensions help modern medicine meet consumer demand for better health with a full range of immediate, delayed, and sustained release options; taste masking; enhanced bioavailability for novel advanced pharmaceutical ingredients; and naturally derived vegetarian capsules. IFFs Pharmaceutical Solutions products are not only used in pharmaceutical applications, but also in food applications and industrial applications, including cosmetics.

The IFF Global Regulatory Affairs organization employs more than 300 highly specialized and committed colleagues worldwide and has a footprint in more than 20 countries. Our work environment is truly international, and we offer a dynamic working culture focused on partnership, cross-organizational collaboration, and individual development opportunities.

The role reports to the Pharma Solutions President and is preferably located in the US, but with some flexibility.

Title: Regulatory Affairs and Product Stewardship (RAPS), Pharmaceutical Solutions (PhS) Director

Pharma Solutions (PhS), an IFF Business, applies expert science to advance market-driven, healthy and sustainable solutions for pharmaceutical, dietary supplement and chemical industries.

In the Global Regulatory Affairs (GRA) team we have an opening for a Regulatory Affairs and Product Stewardship (RAPS) PhS director to lead the global regulatory team supporting the PhS business, and to drive regulatory activities for our ~$1B Pharmaceutical Solutions portfolio of businesses.

IFFs Pharmaceutical Solutions represent one of the industry’s broadest and most flexible portfolio of oral solid dosage advanced pharmaceutical ingredients and excipients. Our solutions for tablets, capsules, multiparticulates and suspensions help modern medicine meet consumer demand for better health with a full range of immediate, delayed, and sustained release options; taste masking; enhanced bioavailability for novel advanced pharmaceutical ingredients; and naturally derived vegetarian capsules. IFFs Pharmaceutical Solutions products are not only used in pharmaceutical applications, but also in food applications and industrial applications, including cosmetics.

The IFF Global Regulatory Affairs organization employs more than 300 highly specialized and committed colleagues worldwide and has a footprint in more than 20 countries. Our work environment is truly international, and we offer a dynamic working culture focused on partnership, cross-organizational collaboration, and individual development opportunities.

The role reports to the Pharma Solutions President and is preferably located in the US, but with some flexibility.

RESPONSIBILITIES / ESSENTIAL FUNCTIONS:

The RAPS PhS director sets the personnel, strategic and technical direction for the regulatory function in full support of the business needs. This role is responsible for the global PhS regulatory team (ca. 30 reports globally).

The role will be member of the Pharma leadership team, and will be responsible for connecting the regulatory changes and requirements impacting the business into the business activities.. The leader will prioritize and drive cross functional regulatory driven programs.

This position bears the ultimate accountability for regulatory compliance and product stewardship for the PhS business.

Specific Responsibilities include:

Lead the strategic planning for the regulatory function, in coordination with the strategic plans for business – across all functions.Lead the regulatory department, including annual goal setting, prioritization, staff assessment and development, training, PMPs (spell out?), budget.  Guide and support existing product portfolio in the different applications, with projects, lifecycle management of product registrations worldwide, including opening new market/applications and introduction of existing products into additional countries / jurisdictions.Active involvement with new projects and new product developments, defining regulatory strategies globally and supporting dossier work on an as needed basis.Ensure that relevant risk evaluation and management processes are followed and completed

Provide and support active customer support on regulatory matters.Proactively identify, support and direct global and regional advocacy needs with reference to API’s, excipients etc. Coordinate and support interface with competent authorities and trade associations (e.g., IPEC, …) to understand regulatory issues of direct impact to the use of IFFs Pharmaceutical Solutions products in finished products in relevant applications. 

Provide regulatory updates and interpretations to internal teams and senior management about global regulatory requirements, guidelines, and trends affecting pharmaceutical excipients, food ingredients, and dietary supplements.

Active translator of regulatory issues to, and interface with R&D, Commercial and Marketing functions to define optimal regulatory pathways aligned with business plans, development opportunities and R&D objectives.Active interpreter of regulatory issues and regulation changes to, interface with business functions, including R&D, Commercial & Marketing, Operations, Quality, and Engineering, to define and execute course of actions needed.Support and coordinate relevant dossiers (e.g. DMF, CEP, GRAS, national) for approval.Coordination of scientific work to support risk assessment (testing program).

EXTERNAL FOCUS:

Expected to spend up to 10-25% of travel time supporting business customer interactions, trade associations or interacting with government officials.

 PREFERRED EXPERIENCE & QUALIFICATIONS:

Extensive  knowledge and experience on the global and/or regional regulatory landscape for PhS actives, excipients and finished products and its applications is mandatoryRegulatory experience with dietary supplement and chemical industries is a plusDemonstrated broad regulatory expertise to represent PhS with customers, within trade associations, authoritiesProven ability to manage large amounts of information, and ability to make both tactical and strategic decisionsMinimum MSc degree, (preferred PhD degree) in Pharmaceutical Science or Regulatory Science,+ 15 years Regulatory Affairs work experience in the Pharmaceutical Industry mainly focused on pharma products.Demonstrated analytical, conceptual and strategic thinkingExcellent oral, written and presentation skills to inform and influence a broad range of internal and external stakeholders.Managerial skills, with experience in leading and developing regulatory affairs teams.Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving regulatory challenges.Proven strong leadership, decision making and interpersonal skillsVery good organization, and strong project management competenciesProven strong negotiation skills with health agenciesStrong influencer and collaborator with interdisciplinary team

We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more